Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic

Status Completed

Clinical Trial Summary

This is an investigator-started study. The trial is coded as no. GC&PJ-Dig-Iva2009-2012.

The authors have no conflict of interest and there was no financial sponsoring The study was planned according to the Good Clinical Quality standards using an intention-to-treat analysis. The protocol was approved from the ethics committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the collected data and analysis. Analysis of collected data was performed by a single-blinded author (without knowledge of the used test drug and time of collection of data).

Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with permanent atrial fibrillation (ischemic etiology).

Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.

Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):

Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection rate, left trial size,diastolic function.

Participants were followed (ambulatory observation) for at least 3 months

Clinical Trial Description

Selected patients had chronic coronary artery disease which had been treated with percutaneous dilatation & stenting and/or aortocoronary bypass. The severity of myocardial ischemia had induced heart failure with diastolic dysfunction and preserved systolic function, and permanent AF.

1 Inclusion criteria:

Dyspnea class III NYHA.

Abnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF).

Patients either in sinus rhythm or with permanent atrial fibrillation.

2. Exclusion criteria:

Unstable angina pectoris.

Reduced systolic cardiac function (LVEF<52%).

Normal diastolic function.

Diabetes requiring insulin.

Moderate or severe renal or hepatic dysfunction.

Technically insufficient echocardiography. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01796093
Study type	Observational [Patient Registry]
Source	Cocco, Giuseppe, M.D.
Contact
Status	Completed
Phase	N/A
Start date	April 2008
Completion date	February 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function — DIGvsIVA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms